Transcutaneous Oxygen Tension Research Articles

Developing a Practical Tool for Predicting Wound Healing Outcomes of Patients with Diabetic Forefoot Ulcers: Focus on Vasculopathy and Infection.

To develop a preliminary risk scoring system to predict the prognosis of patients with diabetic forefoot ulcers based on the severity of vasculopathy and infection, which are the major risk factors for amputation. Forefoot was defined as the distal part of the foot composed of the metatarsal bones and phalanges and associated soft tissue structures. The degree of vasculopathy was graded as V0, V1, or V2 according to transcutaneous partial oxygen tension values and toe pressure. The degree of infection was graded as I0, I1, or I2 according to tissue and bone biopsy culture results. The risk scores were calculated by adding the scores for the degree of vasculopathy and infection and ranged from 0 to 4. Wound healing outcomes were graded as healed without amputation, minor amputation, or major amputation. The authors evaluated wound healing outcomes according to risk scores. As the risk score increased, the proportion of patients who underwent both major and minor amputations increased (P < .001). In the multivariate logistic analysis, the odds ratios of amputation also increased as the risk score increased. Patients with a risk score of 4 were 75- and 19-fold more likely to undergo major and minor amputations, respectively, than patients with a risk score of 0 (P = .006 and P < .001). The risk score can be used as an indicator to predict the probability of amputation in patients with diabetic forefoot ulcers.

Optimization of Transcutaneous Oxygenation Wearable Sensors for Clinical Applications

AbstractIn this manuscript, the development of an experimental and mathematical toolset is reported that allows for improved in vivo measurements of optical transcutaneous oxygen tension measurements (TCOM) wearable technology in humans. In addition to optimizing O2‐sensing films for higher sensitivity oxygen detection, calibration algorithms are additionally developed to account for excitation source leakage, as well as algorithms to combine readings of partial pressure of oxygen (pO2), derived from phosphorescence intensity and lifetime, into a single metric. This new iteration of the TCOM wearable device is then tested in a pilot human study. By implementing characterization and calibration algorithms, the data from the pilot study demonstrates the ability to obtain reliable transcutaneous pO2 readings with a TCOM sensor regardless of size and without the need for strict conditions of constant temperature, humidity, or motion that have limited the range of applications of this technology in the past.

Comparative Evaluation of Transcutaneous Oxygen Tension vs Ankle Brachial Index as Predictors of Need for Below-knee Amputation Revision

Comparative Evaluation of Transcutaneous Oxygen Tension vs Ankle Brachial Index as Predictors of Need for Below-knee Amputation Revision

Pain-related changes in crSO2 among premature infants undergoing PICC insertion

Objective To evaluate the effectiveness of cerebral regional oxygen saturation (crSO2) values, measured using near-infrared spectroscopy (NIRS), in assessing pain associated with the peripherally inserted central catheter (PICC) in premature infants. Methods NIRS was used to measure the crSO2 levels of 48 premature infants with gestational age (GA) of < 32 weeks or a birth weight of < 1500 g. Premature infant pain profile (PIPP) scores, vital signs, transcutaneous oxygen tension (TcpO2), transcutaneous carbon dioxide tension (TcpCO2), and crSO2 values were monitored. One-way repeated measure analysis of variance was used to compare heart rate (HR), respiratory rate (RR), blood pressure (BP), peripheral oxygen saturation (SpO2), TcpO2, TcpCO2, and crSO2 values before (Time 1), during (Time 2), and after (Time 3) PICC insertion. The correlation between the PIPP scores at Time 2 and the fluctuations (values detected at Time 2 minus those at Time 1) of SpO2, TcpO2, and crSO2 were also analyzed. Results The PIPP score at Time 2 was significantly higher than those at Times 1 and 3. HR, RR, and BP values increased (p < .05), and SpO2 and crSO2 levels decreased at Time 2 (p < .05) compared with those at Time 1. Stratified analysis based on GA revealed significant differences in HR, RR, and crSO2 values between Times 1 and 2 in infants with a GA of ≥ 32 weeks. In infants with a GA < 32 weeks, significant differences were observed in HR, RR, SpO2, BP, and crSO2 values between Times 1 and 2. The fluctuation of the crSO2 level was strongly correlated with the PIPP score at Time 2 (r = −0.829, p < .001). A weak correlation was observed between the PIPP score at Time 2 and TcpO2 level fluctuation (r = 0.375, p = .009). No correlation was observed between the PIPP score at Time 2 and SpO2 level fluctuation (r = 0.242, p = .097). Conclusion The fluctuation of crSO2 levels strongly correlates with PICC procedural pain. Hence, crSO2 levels measured using NIRS may be used as an indicator for pain assessment in premature infants.

Clinical utility of 67 Gallium-SPECT/CT for determining osteotomy indication in patients with lower-limb osteomyelitis.

Standard non-invasive methods for diagnosing and selecting the best treatment for osteomyelitis in patients with multiple chronic conditions remain to be established. We aimed to evaluate the ability of quantitative 67 Ga-citrate single-photon emission computed tomography (67 Ga-SPECT/CT) to determine the indication for either non-surgical treatment or osteotomy in patients with lower-limb osteomyelitis (LLOM) associated with diabetes mellitus and lower-extremity ischemia, based on monitoring of inflammatory activity in bone tissue. This single-centre prospective study conducted from January 2012 to July 2017 included 90 consecutive patients with suspected LLOM. Regions of interest were drawn on SPECT images during quantification of Ga accumulation. Subsequently, the inflammation-to-background ratio (IBR) was calculated by dividing the maximal accumulated lesion number by the mean number for the distal femur bone marrow of the unaffected side. Osteotomy was performed in 28 of 90 patients (31%). The osteotomy rate was higher for patients with IBR >8.4 (71.4%) than for those with IBR ≤8.4 (5.5%) (p < 0.001, sensitivity: 0.89, specificity: 0.84). In the multivariate Cox regression analysis, IBR >8.4 was an independent risk factor for osteotomy (hazard ratio [HR]: 19.0, 95% confident interval [CI]: 5.6-63.9, p < 0.001). Transcutaneous oxygen tension (TcPO2 ) was identified as an independent risk factor for lower-limb amputation (HR: 0.96, 95% CI: 0.92-0.99, p=0.01). The current results indicate that quantitative 67 Ga-SPECT/CT is useful for distinguishing patients with LLOM likely to require osteotomy.

Lower Limb Arterial Ischemia: An Independent Risk Factor of Sudomotor Dysfunction in Type 2 Diabetes.

As an early manifestation of diabetic peripheral neuropathy (DPN), sudomotor dysfunction significantly increases the risk of diabetic foot ulcer. The pathogenesis of sudomotor dysfunction is still unclear. Lower limb ischemia may be related to sudomotor dysfunction, but few studies have explored it. The purpose of this study is to explore the relationship between sudomotor function and comprehensive lower limb arterial ischemia including large arteries, small arteries and microvascular in type 2 diabetes mellitus (T2DM). 511 T2DM patients were enrolled in this cross-sectional study. Sudomotor function was assessed qualitatively and quantitatively by Neuropad. Lower limb arterial ischemia was defined as any abnormality of the ankle brachial index (ABI), toe brachial index (TBI) or transcutaneous oxygen tension (TcPO2). In this study, 75.1% of patients had sudomotor dysfunction. Compared with normal sudomotor function, patients with sudomotor dysfunction had a higher incidence of lower limb arterial ischemia (51.2% vs 36.2%, p = 0.004). Similarly, compared with the non-arterial ischemia group, the proportion of sudomotor disorders was higher in the arterial ischemia group (p = 0.004). Low TBI and low TcPO2 groups also had a higher proportion of sudomotor disorders (all p < 0.05).Compare with normal groups, low ABI, low TBI, and low TcPO2 groups had lower Slop4 which quantitatively reflecting Neuropad discoloration. Arterial ischemia was an independent risk factor for sudomotor dysfunction [OR = 1.754, p = 0.024]. Low TcPO2 also independently increased the risk of sudomotor disorders [OR = 2.231, p = 0.026]. Lower limb arterial ischemia is an independent risk factor of sudomotor dysfunction. Especially below the ankle (BTA) small arteries and microvascular ischemia may also be involved in the occurrence of sudomotor disorders.

High-Frequency versus Low-Frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia: Short-Term Results of a Randomized Trial

Introduction: The objective of the study is to determine if high-frequency (1 kHz) spinal cord stimulation (SCS) is better than low-frequency SCS for pain relief in chronic limb-threatening ischemia (CLTI). Methods: HEAL-SCS trial was designed as an open-label, parallel-group, single-center randomized study with a 1:1 allocation ratio. The trial was conducted in Meshalkin National Medical Research Center between August 2018 and February 2020. Total 56 patients underwent screening, 50 were enrolled, 6 were rejected. The participants were randomized into 2 cohorts of 25 patients each by an external coordinator using an online tool. A neurosurgeon and a vascular surgeon both examined all patients and estimated the pain intensity using visual analog scale (VAS), quality of life with short-form-36 health survey (SF-36), and functional status by walking impairment questionnaire (WIQ) at 3 and 12 months. Tissue perfusion was evaluated for 34 patients using transcutaneous oxygen tension measurement (TcPO₂) at baseline and in 12 months. Results: All 50 patients (84% men, median age 66.5 y.o) were available for primary outcome assessment 3 and 12 months after implantation. Intention-to-treat analysis demonstrated comparative advantage of HF-SCS over LF-SCS at 3 months with mean VAS score 2.8 (95% CI, 2.4; 3.2) and 3.3 (95% CI, 3.0; 3.6), respectively (p = 0.031). Clinical superiority of HF-SCS persisted at 12-month follow-up (p < 0.001). HF-SCS produced significantly greater pain relief by WIQ at 3 (p < 0.001) and 12 months (p = 0.009). Despite stair-climbing ability was better in HF-SCS group (p = 0.02), no significant difference between groups was found at 1-year post-op in terms of speed (p = 0.92) and distance scores (p = 0.68). Accordingly, the general and mental health domains of SF-36 were significantly better in HF-SCS at 12 months. Despite a tendency toward better resting oxygen pressure in HF-SCS group, there was no intergroup difference by TcPO₂ (p = 0.076). Only 1 patient (2%) required above-the-knee amputation at 10 months after LF-SCS implantation. Conclusion: High-frequency SCS provides better pain relief, life quality, and functional performance in patients with CLTI during short-term follow-up. The lack of perfusion difference between high-frequency and conventional SCS requires further examination to the possible long-term advantages of the method.

Therapeutic evaluation of calciphylaxis by transcutaneous oxygen tension measurement in a case treated with a combined regimen including sodium thiosulphate

Therapeutic evaluation of calciphylaxis by transcutaneous oxygen tension measurement in a case treated with a combined regimen including sodium thiosulphate

The role of instrumental markers in assessment of microcirculation of type 2 diabetes mellitus patients

Introduction. The development of diagnostic techniques of diabetes mellitus microvascular complications is an urgent task. One such method is laser Doppler flowmetry (LDF). Purpose was to analyze the correlations of clinical and laboratory parameters and LDF spectral parameters in patients with type 2 diabetes mellitus. Materials and methods. The study involved 50 patients with type 2 diabetes and diabetic foot syndrome. Microcirculation was assessed using the BIOPAC LDF 100C system. In parallel, monitoring of transcutaneous oximetry in the probed area was carried out using the TCM400 device. For correlation analysis, the Spearman correlation coefficient was used. Results. While studying, a positive correlation was noted between the contribution of pulse fluctuations and the duration of diabetes (p&lt;0.05). For the level of glycosylated hemoglobin, it was positively correlated with the value of the contribution of pulsed fluxmotions and negatively correlated with the contribution of low-frequency fluxmotions and the fluxmotion index (p&lt;0.05). When assessing transcutaneous oxygen tension, a negative correlation was found with the value of the contribution of pulse fluxmotions (p&lt;0.05). These correlations can be explained in the light of modern concepts of the pathogenesis of type 2 diabetes mellitus microvascular complications. Conclusion. In the course of the work, spectral parameters of LDF were found correlated with clinical, laboratory, and instrumental parameters. The dynamics of changes in LDF parameters corresponds to the ideas about the pathogenesis of diabetic microangiopathy. A promising direction for further research is the study of the progressive development of diabetic microangiopathy and the role of individual pathogenetic factors in this process.

High-frequency spinal cord stimulation in treatment of chronic limb-threatening ischemia (HEAL-SCS): short-term results of a randomized trial

Background. Critical limb ischemia is defined as persistent ischemic pain attributed to a variety of severely compromised blood flow to affected extremities. The treatment of non-reconstructable critical limb ischemia is still challenging; the amputation rate was 9.3%, and mortality rate was 23.2% within 24 months. Spinal cord stimulation (SCS) has become an alternative clinical practice for the treatment of intractable pain of the extremities.Aim. To determine whether high-frequency spinal cord stimulation (SCS) is better than low-frequency SCS for pain relief in chronic limb-threatening ischemia treatment.Methods. Throughout enrollment 56 patients were examined, of whom 6 rejected to participate in the study. The participants were randomly allocated to high-frequency (HF) or low frequency (LF)-SCS groups of 25 patients each by an external statistician, using an online tool. The patients were examined by a neurosurgeon and a vascular surgeon to assess pain intensity by visual analog scale, quality of life by short-form-36 health survey (SF-36), and functional status by walking impairment questionnaire in 3 and 12 months. Tissue perfusion by transcutaneous oxygen tension measurement was also measured in 12 months.Results. Intention-to-treat analysis demonstrated comparative advantage of HF-SCS over LF-SCS in 3 months with mean visual analog scale score 2.8 [95% CI, 2.4; 3.2] and 3.3 [95% CI, 3.0; 3.6] respectively (p = 0.031). Clinical superiority of HF-SCS persisted at 12 months follow up (p&lt;0.001). HF-SCS produces significantly greater pain relief by walking impairment questionnaire in 3 (p&lt;0.001) and 12 months (p = 0.009). Accordingly, general and mental health domains of SF-36 were significantly better in HF-SCS in 12 months. Despite a tendency toward better resting oxygen pressure in HF-SCS group, there was no intergroup difference by transcutaneous oxygen tension (p = 0.076).Conclusion. High-frequency spinal cord stimulation imposes better pain relief, life quality and functional activity in patients with chronic limb-threatening ischemia in short-term follow up.

SURGICAL TREATMENT IMMEDIATE RESULTS OF LOWER LIMBS CHRONIC CRITICAL ISCHEMIA IN IMMULTANEOUS DIRECT AND INDIRECT REVASCULARIZATION

The aim: To assess the immediate results of autovenous femoral-tibial shunting in combination with rotary osteotrepanation of the tibia by studying changes in the transcutaneous ptO2 tension in the tibia and foot tissues depending on the revascularization of the tibial arteries. Materials and methods: We analyzed the treatment of 69 patients with obliterating atherosclerosis of the vessels of the lower extremities. According to the degree of ischemia of the lower extremities, the patients were distributed as follows: III A degree of ischemia - 20 (29%), III B - 28 (40.6%), IV - 21 (30.4%) patients. All patients had atherosclerotic lesions of the popliteal-tibial segment of the great arteries with preserved central blood flow in the aorto-iliac segment. Results: Occlusion of the anterior tibial artery was recorded significantly more often than the peroneal artery (72% and 42%, respectively, p = 0.05), but with the same frequency compared to the posterior tibial artery (68%, p = 0.61). The lesion of two or three arteries of the lower leg was recorded more often than occlusion of one (n = 51; 73.9% and n = 18; 26.1%). Occlusive-stenotic lesion of the popliteal artery was observed in 54 (78.2%) patients. The highest incidence of lesions of the tibial arteries was observed in the basin of the anterior tibial artery in 28 (40.6%) patients. Combined lesions of the anterior tibial artery and posterior tibial artery were diagnosed in 19 (27.5%) patients. Limited lesions of the posterior tibial artery were found in 15 (21.7%) patients. The combination of lesions of the posterior tibial artery and peroneal artery was diagnosed in 7 (10.2%) patients. Conclusions: 1. The patency of the femoral-tibial autovenous shunt during the year was 71%. High limb amputation was performed in 29% of patients. 2. According to CT data, the localization of trophic changes on the foot during critical ischemia of the lower extremities corresponds to the affected segment of the arterial angiosome, which supplies the corresponding area with blood. 3. After femoral-tibial autovenous bypass grafting, the highest levels of transcutaneous oxygen tension were observed in the basin of the posterior tibial artery and peroneal artery, and the lowest indicators of transcutaneous oxygen tension were observed in the basin of the anterior tibial artery. 4. During femoral-tibial autovenous shunting operations in combination with rotary osteotrepanation, the transcutaneous oxygen tension indices increased threefold in the angiosomal basin of the posterior tibial artery and peroneal artery, and twofold in the angiosomes of the dorsum of the foot and sole.

Комплексный подход к лечению неоперабельных пациентов с критической ишемией нижних конечностей и сахарным диабетом: результаты и перспективы

INTRODUCTION: The question of the optimal methods of conservative treatment of patients with critical lower limb ischemia (CLLI) and diabetes mellitus (DM) is still open. AIM: To evaluate the long-term results of therapeutic treatment of patients with CLLI and DM whose peripheral vascular bed is unsuitable for reconstruction, or who refused surgical treatment for different reasons, and to determine effectiveness of additional angiogenesis in this group of patients. MATERIALS AND METHODS: The work involved 65 patients with CLLI and DM who were divided to 2 groups. The control group of patients (40 individuals) received a course of conventional therapy. In the study group (25 individuals), additional exogenous stimulation of angiogenesis was used with angiogenic vascular endothelial growth factor. Subsequently, instrumental parameters of limb perfusion were assessed within 6 months, and in the long-term period (5 years), limb preservation and mortality in this group. RESULTS: Exogenous stimulation of angiogenesis permits to improve the following 6-month treatment results (8% of deaths and 20% of amputations in the study group versus 15% of deaths and 42.5% of amputations in the same period in the control group), and permits to maintain this trend within 5 years of follow-up (64% of deaths and 72% of amputations in the study group versus 80% of deaths and 87.5% of amputations in the control group). Reliable differences between the groups in the frequency of amputations were observed on visits in 6 months (p = 0.041) and in 1 year of follow-up (p = 0.048). According to instrumental data, the best parameters in terms of the painless walking distance (p = 0.032) and transcutaneous oxygen tension were obtained in the study group by 6 months of follow-up (p = 0.028). CONCLUSIONS: Therapeutic angiogenesis improves the results of treatment of patients with CLLI and diabetes mellitus, especially in 6 months — 2 years interval, however, conservative therapy still demonstrates unsatisfactory results of treatment in the near and in the long terms.

Long-term results of proximal and distal reconstructions in patients with lower limb arteries diffuse lesions and diabetes mellitus

Relevance . Treatment of diffuse lesions of the arteries of the lower extremities is often reduced to primary amputation at the hip level, since the healing of trophic ulcers is not guaranteed during arterial reconstruction. Profundoplasty without distal bypass surgery can be considered an alternative method. The aim of this study is to compare the long-term results of distal shunting and isolated profundoplasty in patients with diffuse lesions of the lower limb arteries and trophic ischemic ulcers. Materials and Methods . The study included 86 patients with diffuse lesions of the lower limb arteries. There were 52 (60.4%) men and 34 (39.6%) women. The average age was 67.3 16.8 years. All patients had diffuse lesions of the arteries below the pupar ligament, the state of the lower leg arteries was 5-8.5 points on the Rutherford scale, in all cases there were trophic ulcers. Group 1 included 48 patients who underwent reconstruction of the leg arteries. Group 2 consisted of 38 individuals who had limited intervention with endarcteriotomy from common femoral and deep femoral arteries. Results and Discussion . Amputations at the hip level were performed within a year in 11 (23.4%) patients of group 1 and in 3 (6.3%) patients within 30 days after surgery. Thus, 14 (29.7%) patients lost their limbs. A comparative analysis revealed that the group of patients with amputations had a more severe form of diabetes (p = 0.003), an outflow score on the Rutherford scale (p 0.001), and lower transcutaneous oxygen tension values before and after surgery. Within 12 months after the bypass surgery, the primary patency of the shunts was 65.9% (thrombosis occurred in 16 patients). Conclusion . The preservation of the limb in patients in our study by the end of 1 year after reconstruction is similar regardless of the reconstruction method. Given the minimal invasion during profundoplasty, this operation may be the method of choice for diffuse lesions of the arteries of the lower extremities.

A meta-analysis of randomized controlled trials on therapeutic efficacy and safety of autologous cell therapy for atherosclerosis obliterans

ObjectiveAtherosclerosis obliterans (ASO) is a chronic occlusive arterial disease and the most common type of peripheral arterial disease. Current treatment options like medication and vascularization have limited effects for “no-option” patients, and stem cell therapy is considered a viable option, although its application and efficacy have not been standardized. The objective of this review was to assess the safety and efficacy of autologous stem cell therapy in patients with ASO. MethodsWe performed a literature search of published randomized controlled trials (RCTs) for patients with ASO receiving stem cell therapy without a revascularization option. PubMed, Embase, and the Cochrane Library were searched. This study was conducted by a pair of authors independently and audited by a third author. Data were synthesized with a random-effects model. ResultsA total of 630 patients in 12 RCTs were included. The results showed that cell therapy significantly improved total amputation (relative risk [RR], 0.64; 95% confidence interval [CI], 0.47-0.87; P = .004), major amputation (RR, 0.69; 95% CI, 0.50-0.94; P = .02), ankle-brachial index (mean difference [MD], 0.08; 95% CI, 0.02-0.13; P = .004), transcutaneous oxygen tension (MD, 11.52; 95% CI, 3.60-19.43; P = .004), and rest pain score (MD, −0.64; 95% CI, −1.10 to −0.17; P = .007) compared with placebo or standard care. However, current studies showed cell therapy was not superior to placebo or standard care in all-cause death (RR, 0.75; 95% CI, 0.41-1.36; P = .34) and ulcer size (MD, −8.85; 95% CI, −29.05 to 11.36; P = .39). The number of trials included was limited. Moreover, most trials were designed for “no-option” patients, and thus the results should be applied with caution to other patients with peripheral arterial disease. ConclusionsPatients with ASO can benefit from autologous cell therapy in limb salvage, limb blood perfusion, and rest pain alleviation.

Опыт лечения синдрома диабетической стопы в клинике общей хирургии Военно-медицинской академии им. С.М. Кирова

We examined 180 patients with purulent-necrotic complications of diabetic foot syndrome, in whom the proposed diagnostic algorithm was used. Magnetic resonance imaging of the feet, ultrasound Doppler with duplex angioscanning, magnetic resonance and computed angiography of the lower extremities, as well as assessment of transcutaneous oxygen tension were performed. Surgical treatment tactics depended on the form of the diabetic foot syndrome, as well as the severity of the disease. As a local treatment, physical methods were used to accelerate the course of the wound process. The proposed diagnostic algorithm for the diagnosis and selection of surgical treatment for various forms of diabetic foot syndrome has made it possible to reduce the number of “high” amputations and maintain a supporting limb. Purpose of the study is to improve treatment outcomes for purulent-necrotic complications of diabetic foot syndrome by developing and applying a diagnostic algorithm and differentiated treatment tactics. The main group consisted of 180 patients with purulent-necrotic complications of diabetic foot syndrome, in whom the developed diagnostic algorithm and differentiated tactics of surgical treatment were used, as well as physical methods of influencing the wound process (ultrasonic cavitation and local ozonation) were used as local treatment. The control group included 40 patients with purulent-necrotic complications of diabetic foot syndrome, whose treatment involved the use of drugs that improve the rheological properties of blood and tissue microcirculation (rheopolyglucin, trental, actovegin) according to conventional schemes. Local treatment included sanitation and treatment of wound and ulcerative surfaces with antiseptic solutions and ointments, depending on the phase of the wound process. Data analysis in this group was carried out based on a retrospective study of case histories and an assessment of long-term results of treatment by follow-up examinations and telephone interviews. Control group included 25 (63%) men and 15 (37%) women; the average age was 67.3±10.3 years. The developed unified approaches in diagnosing and treating patients with purulent-necrotic complications of diabetic foot syndrome, who, in complex treatment, underwent staged necrectomy with simultaneous ultrasonic cavitation of purulent wounds and their ozonization, can reliably reduce the number of ulcer recurrences from 28% to 2.7%, high amputations by 34%, and the number of re-amputations ― 10 times. The use of minimally invasive surgical technologies for the rehabilitation of deep purulent foci of the foot, in comparison with the classical principles of treatment of purulent wounds, makes it possible to achieve a complete cleansing of wounds, preparation for plastic surgery, and an increase in the number of functional supportable lower limbs by 42.7%. According to the data obtained, it is optimal to perform sanitizing operations after revascularization of at least one artery no earlier than 3–4 days, which makes it possible to increase their efficiency and reduce the number of repeated surgical interventions. The approach to managing patients with diabetic foot syndrome at all stages of treatment and rehabilitation should be interdisciplinary and include the following specialists: endocrinologist, orthopedist, surgeon, psychologist, trained nursing staff.

The influence of low- intensity laser irradiation versus hyperbaric oxygen therapy on transcutaneous oxygen tension in chronic diabetic foot ulcers: a controlled randomized trial.

Evaluation of the stage and severity of the chronic diabetic foot ulcer (CDFU) is vital to increase the healing rate andto select the suitable treatment. We aim to assess the influence of low-intensity laser irradiation (LILI) and hyperbaric oxygenation therapy (HBOT) to acceleratethe CDFU healing thru the transcutaneous oxygen tension (TcPO2) measurements. Seventy-five diabetic patients (type 2) of both genders, their ages ranged from 40-65years with CDFUs (duration of ulcer < 6weeks). All patients were randomly assigned into LILI, HBOT, and the control group. Measurement of TcPO2 using transcutaneous oximetry was performed for all patients once in the baseline and consequently in the second, fourth, and sixth- weeks duration. LILI utilized by a 33-diode cluster contact applicator with output power 1440 mW, energy density (fluency) was adjusted for 4J/Cm2 at 10kHz, and for 8min per session, three times per week for a total of consecutive 6weeks. HBOT was pressurized up to 2.5 ATA and patients delivered 100% oxygen for 60min per session for 30 sessions. The Control group received conventional wound care only, twice daily, with saline and apply a new bandage after cleaning. MANOVA revealed a statistically insignificant difference in the control group, while statistically significant improvement in both the LILI and HBOT groups. The intergroup comparisons showed an insignificant statistical difference in the pre-test, while highly statistically significant differences for the three post-measures in favor of HBOT and LILI groups. The percentage of improvement of the HBOT group was higher than LILI. Post-hoc test using the least significant difference (LSD) revealed statistically significant differences of HBOT in favor of the LILI group. Both LILI and HBOT may be used as adjunctive methods to improve TcPO2 that accelerate healing in CDFUs. HBOT may be favorable in the improvement of TcPO2 than LILI.

Feasibility of Photo-Optical Transcutaneous Oxygen Tension Measurement During Revascularization of the Lower Extremity

ObjectivesA novel approach in the evaluation of peripheral arterial disease is the photo-optical oxygen tension measurement (pTCpO2). This modality is suggested to be more practical in use in comparison to standard electro-chemical oxygen tension measurement. Hence, pTCpO2 might be of added value to evaluate revascularization of the lower extremities peri-procedural. We conducted a preliminary feasibility study to analyze the potential of pTCpO2 during revascularization. MethodsTen patients scheduled for revascularization of the lower extremities were enrolled. pTCpO2 values of the affected lower extremity were measured pre-operatively, during revascularization and after revascularization. Results were compared to the pre- and postoperative ankle-brachial index (ABI) and to perioperative angiography. Primary endpoint was the feasibility of perioperative pTCpO2 measurement. Secondary endpoints were concordance between pTCpO2, ABI, angiography and clinical outcome. ResultsTwo out of twelve measurements were unsuccessful. Eight out of ten patients experienced significant clinical improvement and pTCpO2 increase. Two patients that did not experience clinical improvement corresponded with no changes in intraoperative angiography and without increase in ABI or pTCpO2. A significant and strong correlation was found between prior and after revascularization ABI and pTCpO2 measurements (r = 0.82 P = 0.04). ConclusionsPhoto-optical transcutaneous oxygen tension measurement may serve as an intraoperative tool to evaluate the success of revascularization. pTCpO2 could be an alternative for the ABI to determine the success of lower extremity revascularization.

Comparison of Photo-optical Transcutaneous Oxygen Tension Measurement with Electro-chemical Transcutaneous Oxygen Tension Measurement in Patients with Arterial Claudication

Photo-optical TCpO2 (pTCpO2) has been proposed as a new method to determine the partial oxygen pressure of the lower extremity in patients with peripheral arterial disease. It is aimed to determine the level of agreement between pTCpO2 and the traditional electro-chemical transcutaneous oxygen tension measurement (eTCpO2). Eighteen patients with intermittent claudication underwent simultaneous ankle-brachial index measurement, toe-pressure, pTCpO2 and eTCpO2 tests. Oxygen tension levels were measured on anterior chest and calf prior in rest (T0), during induced ischemia (T1) and after blood flow restoration (T2). TCpO2 agreement was assessed according to the principles of Bland and Altman. Absolute average TCpO2 values differed between eTCpO2 and pTCpO2 for calf in T2 (38,1 mmHg (σ 14,4) vs. 49,8 (σ 22.3) with P=0.35). The Bland-Altman plots demonstrated eTCpO2 and pTCpO2 bias of 3,7 mmHg (σ 18,8), 11,6 mmHg (σ 17,6) and 6,7 mmHg (σ 23,5) for T0, T1 and T2 for the calf. pTCpO2 is in agreement with eTCpO2 in measuring pO2 levels of the lower extremity in rest and during induced ischemia in patients with vascular claudication. The large variability between eTCpO2 and pTCpO2 should be accounted for, while pTCpO2 values have a tendency to demonstrate higher values in comparison to eTCpO2.

Peripheral blood mononuclear cell transplantation to treat no-option critical limb ischaemia: effectiveness and safety.

Local intramuscular transplantation of granulocyte colony-stimulating factor (G-CSF)-mobilised peripheral blood mononuclear cells (PB-MNC) has been shown to be effective for treating patients with no-option critical limb ischaemia (CLI) who are not considered suitable to undergo surgical bypass or percutaneous transluminal angioplasty. The aim of this study was to investigate the effectiveness and safety of PB-MNCs as a treatment for no-option CLI patients. This prospective cohort study was conducted between April 2013 and December 2017. Patients with no-option CLI were treated with G-CSF 5-10 µg/kg/day for 3 days. PB-MNCs (7.1±2.2×1010) with CD34+ cells (2.1±1.2×108) were collected by blood cell separator and then injected into the calf or thigh of ischaemic limbs. Ankle-brachial index, toe-brachial index and transcutaneous oxygen tension were recorded at 1 and 3 months after injection. The amputation rate and the wound healing rate were also recorded. Eight patients took part in the study. Two patients experienced rest pain relief 1 month after PB-MNC therapy. Five patients had healed ulcer at 6 months after PB-MNC therapy. Limb ischaemia did not improve after PB-MNC therapy in one patient. Below-knee amputation was performed in that patient due to extension of gangrene. Two patients required reinjection of PB-MNCs because of recurrence of ischaemic ulcer. The limb salvage rate after 1 year was 87.5%. Local intramuscular transplantation of G-CSF-mobilised PB-MNCs might be a safe and effective treatment for no-option CLI patients.

Analysis of biomonitoring data after full-thickness skin grafting.

Skin graft vascularization is investigated mainly by histological evaluation. Immunohistochemical analysis has been conducted only in mice. Transcutaneous oxygen tension (TcPO2 ), which is an index of blood flow, has not been evaluated in skin grafts and only a few studies have reported biologic monitoring data using color tone evaluation and surface temperature. In humans, these tests can be performed non-invasively. To evaluate human skin graft vascularization, we analyzed biomonitoring data after skin grafting. We evaluated 14 patients who underwent skin grafting surgery at Nagoya City University Hospital. The TcPO2 , color tone, surface temperature, and dermoscopic observations at recipient sites were measured at postoperative day (POD) 4, 6, and 11. Mean TcPO2 levels at POD4, 6, and 11 were 12.7, 15.2, and 33.5mmHg, respectively, and significantly higher at POD11 than at POD4 (p=0.003, Steel-Dwass test). Dermoscopic observation revealed gradually increasing redness and yellowness. Color tone evaluation measured by spectrophotometry supported the appearance. The a*(redness) value at POD4, 6, and 11 was 6.19, 9.20, and 11.27, respectively, and significantly higher at POD11 than at POD4 (p<0.001, Steel-Dwass test). The b*(yellowness) value at POD4, 6, and 11 was 8.83, 9.24, and 13.02, respectively, and significantly higher at POD11 than at POD4 (p=0.020, Steel-Dwass test). The surface temperature did not significantly differ between graft and control sites. These findings suggest that skin graft vascularization started by POD6 and stabilized by POD11. Because TcPO2 increases after POD4, skin grafts should remain undisturbed until at least POD11.